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NIDEK Receives FDA Clearance for the OPD-ScanTM
New device combines Dynamic Skiascopy with corneal topography to offer "Wavefront PlusTM"


-Fremont CA, USA, April 3, 2001-

NIDEK, Inc. announced today that the Food and Drug Administration has granted 510(k) clearance for the OPD-Scan diagnostic system. NIDEK's new OPD (Optical Path Difference) Scan is a state-of-the-art diagnostic instrument that combines Dynamic Skiascopy technology and Placido disk corneal topography to create unique refractive power maps that show the total optical system aberrations within the individual eyes of each patient. NIDEK can now market and sell the OPD-Scan as a stand-alone device that generates refractive eye maps.

NIDEK's OPD-Scan produces diagnostic image maps to provide high resolution (1,440 measure-ment points for total aberration and autorefractor measurements, and 6,480 points or more for corneal topography measurements), a wide measurement range

(-20 to +22 diopters, with up to 12 diopters of cylinder), and a common axis of measurement for optical aberrations and corneal topography. The OPD-Scan also incorporates autorefraction, allowing simultaneous data acquisition for all measurements in both timeline and axis.

"The technology in the OPD-Scan is a step beyond wavefront devices utilizing the Hartmann-Shack measurement method," said Hiroshi Okada, General Manager and Vice President of NIDEK Inc. "This is why we have coined the term "Wavefront Plus". With one machine, eye care clinicians can create comprehensive, refractive power maps that normally require at least two tests on two different machines. This technology will help them identify the optimum outcome for their patients."

For more information, please contact NIDEK, Inc. by phone (800) 223-9044.


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